Reducing Fear and Anxiety in Children Through Free Play

NCT07335458 | Completed

• 2 other identifiers: E.229701OKÜBAP2025-GAP004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to determine the effect of free-play activities on preoperative fear and state anxiety in children aged 5-10 years and on parental anxiety. The research was conducted as a randomized controlled trial. The study population consisted of children aged 5-10 years and their parents who underwent planned surgical procedures in the pediatric surgery ward of a training and research hospital. Eligible child-parent dyads were recruited using a convenience sampling method and were then randomly assigned to the intervention and control groups. The data collection process in the study was conducted in two stages, with intervention and control groups: pretest and posttest. Tests for both groups were administered before the planned surgical procedure. A pretest for the children and their parents in the intervention group was administered approximately 2 hours before the surgical procedure, just before the start of the free-play intervention. At this stage, baseline data were obtained by measuring the children's fear and state anxiety levels and the parents' anxiety levels. Following this, the children participated in approximately 40 minutes of child-directed free play. A posttest was administered immediately after the free-play intervention, approximately 20 minutes before surgery. This measurement was used to evaluate the effect of free play on the dependent variables. In the control group, no study-related intervention was applied, and routine preoperative care continued. This group was also assessed with a pretest approximately 2 hours before surgery and a posttest after the corresponding 40-minute period, approximately 20 minutes before surgery, to evaluate the children's fear and state anxiety levels and parental anxiety. This allowed the differences between the two groups to be compared. This timing was selected to assess children's anxiety and fear during the period when preoperative distress was expected to be high and to evaluate the immediate effect of free play. Study Population: The study population consisted of children aged 5-10 years who underwent elective surgical procedures and their parents. Study Sample: The study included children aged 5-10 years who underwent surgical procedures and one accompanying parent for each child. The child-parent dyads were randomly assigned to the intervention and control groups. An a priori power analysis was performed using G\*Power version 3.1.9.7. Based on Cohen's d = 0.65, an α level of .05, statistical power of 80%, and a 1:1 allocation ratio, at least 39 child-parent dyads were required in each group. To account for potential attrition or missing data, 80 child-parent dyads were recruited, with 40 assigned to the intervention group and 40 assigned to the control group. The hypotheses of the study were: H1a: The posttest Children's Fear Scale scores of children in the free-play group are lower than their pretest scores. H1b: Children in the free-play group have lower posttest Children's Fear Scale scores than children in the control group. H2a: The posttest Children's Anxiety Meter-State scores of children in the free-play group are lower than their pretest scores. H2b: Children in the free-play group have lower posttest Children's Anxiety Meter-State scores than children in the control group. H3a: Parents in the free-play group have lower posttest anxiety scores than their pretest scores. H3b: Parents in the free-play group have lower posttest anxiety scores than parents in the control group. H4: There are positive associations among parental anxiety, children's state anxiety, and children's fear levels both before and after the intervention.

Conditions

Pediatric Nursing; Preoperative Anxiety; Parental Anxiety; Preoperative Fear

Keywords

Free play; Game-based intervention; Child-Directed Free Play; Pediatric Surgery; Family-Centered Care; Nonpharmacological Intervention

Outcome Measures

Primary Outcomes (2)

• Change in Children's State Anxiety

  Children's state anxiety was assessed using the Children's Anxiety Meter-State. Scores range from 0 to 10, with higher scores indicating greater state anxiety.

  Baseline approximately 2 hours before surgery and immediately after the 40-minute intervention or corresponding control period, approximately 20 minutes before surgery

• Change in Parental Anxiety

  Parental anxiety was assessed using the Visual Analog Scale for Anxiety. Scores range from 0 to 100, with higher scores indicating greater anxiety.

  Baseline approximately 2 hours before surgery and immediately after the 40-minute intervention or corresponding control period, approximately 20 minutes before surgery

Secondary Outcomes (1)

• Change in Children's Fear

  Baseline approximately 2 hours before surgery and immediately after the 40-minute intervention or corresponding control period, approximately 20 minutes before surgery

Study Arms (2)

Child-Directed Free-Play Group

EXPERIMENTAL

Children assigned to the intervention group participated in child-directed free play in the play and learning center approximately 60 minutes before surgery. Each session lasted approximately 40 minutes, and one parent accompanied the child. Children independently selected the play materials and type of play and determined how the play progressed. No therapeutic, educational, or medical guidance was provided. The facilitator did not direct the play and only ensured the child's safety.

Behavioral: Child-Directed Free Play

Routine Preoperative Care Group

NO INTERVENTION

Children assigned to the control group received routine preoperative care, including verification of patient identity and fasting status, monitoring of vital signs, surgical preparation, and standard nursing care. During the period corresponding to the free-play intervention, children remained with their parents in the routine clinical setting and received no study-related play intervention.

Interventions

Child-Directed Free Play BEHAVIORAL

A 40-minute child-directed free-play session conducted approximately 60 minutes before surgery. Children independently selected the play materials and directed the play while accompanied by one parent. The facilitator provided no therapeutic, educational, or medical guidance and only ensured the child's safety.

Child-Directed Free-Play Group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children:
• Aged 5-10 years
• Scheduled to undergo ambulatory or inpatient surgery
• No chronic or neurological disease
• No cognitive, hearing, or visual impairment that could interfere with communication or completion of the study instruments
• Willing to participate and able to provide verbal assent
• Parents:
• Literate
• Accompanying the child during the preoperative period
• Willing to provide written informed consent

You may not qualify if:

• Previous psychiatric diagnosis
• Current use of anxiolytic or sedative medication

Sponsors & Collaborators

• Osmaniye Korkut Ata University: lead

Study Sites (1)

Osmaniye Korkut Ata University

Osmaniye, Osmaniye, 80010, Turkey (Türkiye)

Location

Study Officials

• Mustafa KARA, PhD

  Osmaniye Korkut Ata University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 13, 2026
• Study Start: August 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

TU (1)